Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

sanofi-aventis - asparaginase - solution - 10000 iu

European Union - English - EMA (European Medicines Agency)

baxalta innovations gmbh - pegaspargase - precursor cell lymphoblastic leukemia-lymphoma - antineoplastic agents, - oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (all) in paediatric patients from birth to 18 years, and adult patients.,

European Union - English - EMA (European Medicines Agency)

jazz pharmaceuticals ireland limited - crisantaspase - precursor cell lymphoblastic leukemia-lymphoma - antineoplastic agents - enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (all) and lymphoblastic lymphoma (lbl) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to e. coli-derived asparaginase.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

servier malaysia sdn bhd - pegaspargase -

Ireland - English - HPRA (Health Products Regulatory Authority)

jazz pharmaceuticals france sas - cristanspase - powder for solution for injection - 10000  international unit(s) - other antineoplastic agents; asparaginase

United States - English - NLM (National Library of Medicine)

pegaspargase (unii: 7d96ir0ppm) (pegaspargase - unii:7d96ir0ppm) - injection, solution - 750 [iu] in 1 ml - oncaspar® is indicated as a component of a multi-agent chemotherapeutic regimen for the first line treatment of patients with all. oncaspar® is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with all and hypersensitivity to native forms of l-asparaginase. - history of serious allergic reactions to oncaspar® - history of serious thrombosis with prior l-asparaginase therapy - history of pancreatitis with prior l‑asparaginase therapy - history of serious hemorrhagic events with prior l-asparaginase therapy pregnancy category c . animal reproduction studies have not been conducted with oncaspar® . it is also not known whether oncaspar® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. oncaspar® should be given to a pregnant woman only if clearly needed. it is not known whether oncaspar® is excreted in human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reacti

United States - English - NLM (National Library of Medicine)

baxalta us inc. - pegaspargase (unii: 7d96ir0ppm) (pegaspargase - unii:7d96ir0ppm) - pegaspargase 750 [iu] in 1 ml - oncaspar® is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with all. oncaspar is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with all and hypersensitivity to native forms of l-asparaginase. oncaspar is contraindicated in patients with a: - history of serious hypersensitivity reactions, including anaphylaxis, to oncaspar or to any of the excipients [see warnings and precautions (5.1)] . - history of serious thrombosis with prior l-asparaginase therapy [see warnings and precautions (5.2)] . - history of pancreatitis, including pancreatitis related to prior l-asparaginase therapy [see warnings and precautions (5.3)] . - history of serious hemorrhagic events with prior l-asparaginase therapy [see warnings and precautions (5.5)] . - severe hepatic impairment [see warnings and precautions (5.6)] . risk summary there are no available data on the use of oncaspar i

United States - English - NLM (National Library of Medicine)

deseret biologicals, inc. - viscum album fruiting top (unii: bk9092j5mp) (viscum album fruiting top - unii:bk9092j5mp), cobaltous gluconate (unii: 26sk597uwv) (cobaltous cation - unii:ai1mr454xg), cupric sulfate (unii: lrx7aj16dt) (cupric cation - unii:8cbv67279l), ferrous fumarate (unii: r5l488ry0q) (ferrous cation - unii:gw89581owr), potassium asparaginate (unii: p1cvx5fd7y) (potassium cation - unii:295o53k152), magnesium asparaginate (unii: 28d9fp2q0s) (magnesium asparaginate - unii:28d9fp2q0s), manganese gluconate (unii: 9yy2f980s - viscum album fruiting top 3 [hp_x] in 1 ml - temporary relief of symptoms related to mineral imbalance in the body including fatigue, dehydration, nervousness and cramping pains.  temporary relief of symptoms related to mineral imbalance in the body including fatigue, dehydration, nervousness and cramping pains.

United States - English - NLM (National Library of Medicine)

deseret biologicals, inc. - viscum album fruiting top (unii: bk9092j5mp) (viscum album fruiting top - unii:bk9092j5mp), cobaltous gluconate (unii: 26sk597uwv) (cobaltous cation - unii:ai1mr454xg), cupric sulfate (unii: lrx7aj16dt) (cupric cation - unii:8cbv67279l), ferrous fumarate (unii: r5l488ry0q) (ferrous cation - unii:gw89581owr), potassium asparaginate (unii: p1cvx5fd7y) (potassium cation - unii:295o53k152), magnesium asparaginate (unii: 28d9fp2q0s) (magnesium asparaginate - unii:28d9fp2q0s), manganese gluconate (unii: 9yy2f980s - viscum album fruiting top 3 [hp_x] in 1 ml - indications: for temporary relief of symptoms related to mineral imbalance in the body including fatigue, dehydration, nervousness and cramping pains. indications: for temporary relief of symptoms related to mineral imbalance in the body including fatigue, dehydration, nervousness and cramping pains.

Australia - English - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - methotrexate, quantity: 100 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; water for injections - antineoplastic chemotherapy - methotrexate has a broad spectrum of antineoplastic activity. it is indicated for the treatment of breast cancer, gestational choriocarcinoma, and in patients with chorioadenoma destruens and hydatidiform mole. methotrexate may be used in combination with other chemotherapeutic agents for the palliative treatment of acute leukaemias, particularly acute lymphoblastic leukaemia. it may also be used in the treatment of burkitt's lymphoma, advanced stages (iii and iv, peters' staging system) of lymphosarcoma, especially in children, and in advanced cases of mycosis fungoides. high dose therapy - in high-dose schedules, methotrexate may be effective alone or in combination therapy, in the treatment of epidermoid cancers of the head and neck, osteogenic sarcoma and bronchogenic carcinoma. calcium folinate (leucovorin calcium) must be used in conjunction with high dose methotrexate therapy. psoriasis chemotherapy (see warning box) - methotrexate may be of value in the symptomatic control of severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of treatment. however, due to the high risk associated with its use, methotrexate should be used after the diagnosis has been definitely established, as by biopsy and/or after dermatologic consultation.